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Efficacy of Educating Physical Therapists in the Treatment of Patients With Nonspecific Chronic Low Back Pain

Primary Purpose

Back Pain

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Control

Trained

About this trial

This is an interventional treatment trial for Back Pain focused on measuring back pain, low back pain, chronic low back pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 pain numerical rating scale, aged between 18 and 65 years.
physiotherapists who treat exclusively patients with musculoskeletal pain, duly accredited by the National Council of Physical Therapy, physiotherapists offering private or medical insurance treatment individually to their patients, lasting 50-60 minutes each session, physiotherapists from 2 to five years of graduation and / or working in the area for the same period, that treat at least 2 patients with low back pain per month, and who are willing to treat at least 10 patients for the study.

Exclusion Criteria:

patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy.
physiotherapists who want to stop the activities for some reason that prevents participation in the study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Untrained Physical Therapists

Trained Physical Therapists

Arm Description

The patients allocated to the Control group will be treated by physical therapists who did not receive any training about clinical practice guidelines and pain management. These patients will receive the usual care from their physical therapists.

The patients allocated to the Experimental group will be treated by physical therapists who received training about clinical practice guidelines and pain management.

Outcomes

Primary Outcome Measures

Pain intensity (Pain NRS)

Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

Disability (24-item Roland Morris Disability Questionnaire)

Disability will be measured by the 24-item Roland Morris Disability Questionnaire

Secondary Outcome Measures

Pain intensity (Pain NRS)

Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

Disability ( 24-item Roland Morris Disability Questionnaire)

Disability will be measured by the 24-item Roland Morris Disability Questionnaire

Fear Avoidance Beliefs (FABQ)

Fear avoidance belief will be measured by the 16-item Fear Avoidance Belief Questionnaire (FABQ)

Pain Catastrophizing (PCS)

Pain Catastrophizing will be measured by the 13-item Pain Catastrophizing Scale (PCS)

Full Information

NCT ID

NCT02417402

First Posted

April 7, 2015

Last Updated

October 24, 2017

Sponsor

Universidade Cidade de Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02417402

Brief Title

Efficacy of Educating Physical Therapists in the Treatment of Patients With Nonspecific Chronic Low Back Pain

Official Title

Efficacy of Educating Physical Therapists on Clinical Practice Guidelines and Pain Management in the Treatment of Patients With Nonspecific Chronic Low Back Pain: a Cluster Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Withdrawn

Why Stopped

We had many issues related to recruitment. After many attempts we want to suspend the study with 13 patients.

Study Start Date

May 2015 (undefined)

Primary Completion Date

July 2016 (Anticipated)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Cidade de Sao Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this trial is to investigate if patients treated by physical therapists who received an update on clinical practice guidelines and pain management have better outcomes than patients treated by physical therapists who did not received such training.

Detailed Description

The training "Update on the treatment of patients with nonspecific chronic low back pain" will be announced in the social network by members of the study. Interested physical therapists will send an email to one of the study authors with their information regarding the inclusion criteria. After two months of notice, interested and eligible physiotherapists will be randomized into two groups of 15 participants each. The study arms are: 1) control group (physical therapist who will not receive training) and 2) experimental group (physical therapist who will receive training). Before and after training, attitudes, beliefs and knowledge about low back pain guidelines will be evaluated. Each physical therapist will recruit for the study a total of fifteen consecutive patients with chronic nonspecific low back pain (total sample=150 patients). All the patients will be assessed before the first session by a blinded examiner who will be unaware about the group allocation. Clinical outcomes (pain, disability, fear avoidance beliefs and pain catastrophizing) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain

Keywords

back pain, low back pain, chronic low back pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Untrained Physical Therapists

Arm Type

Active Comparator

Arm Description

Arm Title

Trained Physical Therapists

Arm Type

Experimental

Arm Description

The patients allocated to the Experimental group will be treated by physical therapists who received training about clinical practice guidelines and pain management.

Intervention Type

Other

Intervention Name(s)

Control

Other Intervention Name(s)

physical therapist education, guidelines implementation

Intervention Description

The patients allocated to the Control group will be treated by physical therapists who did not carry out the training before treatment. The physical therapists will use their usual care for nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.

Intervention Type

Other

Intervention Name(s)

Trained

Other Intervention Name(s)

physical therapist education, guidelines implementation

Intervention Description

The patients allocated to the Experimental group will be treated by physical therapists who carried out the training before treatment. The training will be designed to guide the physical therapists beliefs and attitudes to a biopsychosocial model; update knowledge contained in clinical practice guidelines; and enable physical therapists to identify, integrate and address psychosocial factors in patients with nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.

Primary Outcome Measure Information:

Title

Pain intensity (Pain NRS)

Description

Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

Time Frame

5 weeks after randomization

Title

Disability (24-item Roland Morris Disability Questionnaire)

Description

Disability will be measured by the 24-item Roland Morris Disability Questionnaire

Time Frame

5 weeks after randomization

Secondary Outcome Measure Information:

Title

Pain intensity (Pain NRS)

Description

Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

Time Frame

3 and 6 months after randomization

Title

Disability ( 24-item Roland Morris Disability Questionnaire)

Description

Disability will be measured by the 24-item Roland Morris Disability Questionnaire

Time Frame

3 and 6 months after randomization

Title

Fear Avoidance Beliefs (FABQ)

Description

Fear avoidance belief will be measured by the 16-item Fear Avoidance Belief Questionnaire (FABQ)

Time Frame

5 weeks, 3 months and 6 months after randomization

Title

Pain Catastrophizing (PCS)

Description

Pain Catastrophizing will be measured by the 13-item Pain Catastrophizing Scale (PCS)

Time Frame

5 weeks, 3 months and 6 months after randomization

Other Pre-specified Outcome Measures:

Title

Pain attitudes and beliefs for physiotherapists (PABS.PT)

Description

Pain Attitudes and Beliefs will be measured by the 19-item Pain Attitudes and Beliefs Scale for Physiotherapists (PABS.PT)

Time Frame

Baseline and 5 weeks after randomization

Title

Adherence to guidelines for physiotherapists (0-100% Low Back Pain Vignettes)

Description

Adherence to guidelines for physiotherapist will be measured by the 0-100% Low Back Pain Vignettes

Time Frame

Baseline and 5 weeks after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 pain numerical rating scale, aged between 18 and 65 years. physiotherapists who treat exclusively patients with musculoskeletal pain, duly accredited by the National Council of Physical Therapy, physiotherapists offering private or medical insurance treatment individually to their patients, lasting 50-60 minutes each session, physiotherapists from 2 to five years of graduation and / or working in the area for the same period, that treat at least 2 patients with low back pain per month, and who are willing to treat at least 10 patients for the study. Exclusion Criteria: patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy. physiotherapists who want to stop the activities for some reason that prevents participation in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leonardo OP Costa, PhD

Organizational Affiliation

Universidade Cidade de São Paulo

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Educating Physical Therapists in the Treatment of Patients With Nonspecific Chronic Low Back Pain

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